Reservoir plunger head systems and methods

ABSTRACT

A casing may be configured to envelop at least a portion of a plunger arm attached to a plunger head located in a reservoir. A plunger head moveable in a reservoir may have a front portion comprising a first material compatible with fluidic media in an interior volume of the reservoir. A seal member having a first end and a second end that taper to a mid-portion may be positioned between a reservoir and a plunger head. A bias member may be configured to force a plunger arm operatively connected to a plunger head against a drive member to operatively engage the plunger arm to the drive member. A plunger head moveable in a reservoir may have a first ridge, a second ridge, a seal member adjacent at least one of the ridges, and protrusions arranged around at least one of the ridges.

CROSS-REFERENCE TO RELATED PATENT APPLICATIONS

This application claims priority from Provisional Application U.S.Application 61/044,269, filed Apr. 11, 2008, incorporated herein byreference in its entirety.

BACKGROUND

1. Field of the Invention

Embodiments of the present invention relate generally to systems andmethods that include reservoirs for containing fluidic media and havingmovable plungers and, in specific embodiments, to infusion mediumdelivery systems and methods employing such reservoirs.

2. Related Art

According to modern medical techniques, certain chronic diseases may betreated by delivering a medication or other substance to the body of apatient. For example, diabetes is a chronic disease that is commonlytreated by delivering defined amounts of insulin to a patient atappropriate times. Traditionally, manually operated syringes and insulinpens have been employed for delivering insulin to a patient. Morerecently, modern systems have been designed to include programmablepumps for delivering controlled amounts of medication to a patient.

Pump type delivery devices have been configured in external devices,which connect to a patient, and have been configured in implantabledevices, which are implanted inside of the body of a patient. Externalpump type delivery devices include devices designed for use in astationary location, such as a hospital, a clinic, or the like, andfurther include devices configured for ambulatory or portable use, suchas devices that are designed to be carried by a patient, or the like.External pump type delivery devices may contain reservoirs of fluidicmedia, such as, but is not limited to, insulin. External pump typedelivery devices may be connected in fluid flow communication to apatient or user-patient, for example, through a suitable hollow tubing.The hollow tubing may be connected to a hollow needle that is designedto pierce the skin of the patient and to deliver fluidic media therethrough. Alternatively, the hollow tubing may be connected directly tothe patient as through a cannula, or the like.

Examples of some external pump type delivery devices are described inU.S. patent application Ser. No. 11/211,095, filed Aug. 23, 2005, titled“Infusion Device And Method With Disposable Portion” and Published PCTApplication WO 01/70307 (PCT/US01/09139) titled “Exchangeable ElectronicCards For Infusion Devices” (each of which is owned by the assignee ofthe present invention), Published PCT Application WO 04/030716(PCT/US2003/028769) titled “Components And Methods For Patient InfusionDevice,” Published PCT Application WO 04/030717 (PCT/US2003/029019)titled “Dispenser Components And Methods For Infusion Device,” U.S.Patent Application Publication No. 2005/0065760 titled “Method ForAdvising Patients Concerning Doses Of Insulin,” and U.S. Pat. No.6,589,229 titled “Wearable Self-Contained Drug Infusion Device,” each ofwhich is incorporated herein by reference in its entirety.

External pump type delivery devices may be connected in fluid-flowcommunication to a user-patient, for example, through a suitable hollowtubing. The hollow tubing may be connected to a hollow needle that isdesigned to pierce the user-patient's skin and deliver an infusionmedium to the user-patient. Alternatively, the hollow tubing may beconnected directly to the user-patient as or through a cannula or set ofmicro-needles.

In contexts in which the hollow tubing is connected to the user-patientthrough a hollow needle that pierces the user-patient's skin, a manualinsertion of the needle into the user-patient can be somewhat traumaticto the user-patient. Accordingly, insertion mechanisms have been made toassist the insertion of a needle into the user-patient, whereby a needleis forced by a spring to quickly move from a retracted position into anextended position. As the needle is moved into the extended position,the needle is quickly forced through the user-patient's skin in asingle, relatively abrupt motion that can be less traumatic to certainuser-patients as compared to a slower, manual insertion of a needle.While a quick thrust of the needle into the user-patient's skin may beless traumatic to some patient's than a manual insertion, it is believedthat, in some contexts, some patients may feel less trauma if the needleis moved a very slow, steady pace. Examples of insertion mechanisms thatmay be used with and may be built into a delivery device are describedin: U.S. patent application Ser. No. 11/645,435, filed Dec. 26, 2006,titled “Infusion Medium Delivery system, Device And Method With NeedleInserter And Needle Inserter Device And Method,”; and U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, titled “InfusionDevice And Method With Disposable Portion” (each of which is assigned tothe assignee of the present invention), each of which is incorporatedherein by reference in its entirety. Other examples of insertion toolsare described in U.S. Patent Application Publication No. 2002/0022855,titled “Insertion Device For An Insertion Set And Method Of Using TheSame” (assigned to the assignee of the present invention), which isincorporated herein by reference in its entirety. Other examples ofneedle/cannula insertion tools that may be used (or modified for use) toinsert a needle and/or cannula, are described in, for example U.S.patent application Ser. No. 10/389,132 filed Mar. 14, 2003, and entitled“Auto Insertion Device For Silhouette Or Similar Products,” and/or U.S.patent application Ser. No. 10/314,653 filed Dec. 9, 2002, and entitled“Insertion Device For Insertion Set and Method of Using the Same,” bothof which are incorporated herein by reference in their entirety.

As compared to syringes and insulin pens, pump type delivery devices canbe significantly more convenient to a user-patient, in that accuratedoses of insulin may be calculated and delivered automatically to auser-patient at any time during the day or night. Furthermore, when usedin conjunction with glucose sensors or monitors, insulin pumps may beautomatically controlled to provide appropriate doses of infusion mediumat appropriate times of need, based on sensed or monitored levels ofblood glucose.

Pump type delivery devices have become an important aspect of modernmedical treatments of various types of medical conditions, such asdiabetes. As pump technologies improve and as doctors and user-patientsbecome more familiar with such devices, the popularity of externalmedical infusion pump treatment increases and is expected to increasesubstantially over the next decade.

SUMMARY OF THE DISCLOSURE

A system for transferring fluidic media in accordance with an embodimentof the present invention may include, but is not limited to, a reservoirbody, a plunger head, a plunger arm, and a casing. The reservoir bodymay have an interior volume for containing fluidic media. The plungerhead may be moveable in an axial direction within the reservoir body.The plunger arm may be operatively connected to the plunger head. Thecasing may extend from the reservoir body. The casing may allow theplunger arm to move in the axial direction relative to the reservoirbody to move the plunger head in the axial direction within thereservoir body.

In various embodiments, the plunger arm may have at least one sideadjacent the casing and at least partially supported by the casing toalign the plunger arm for movement in the axial direction relative tothe reservoir body.

In various embodiments, the plunger arm may have an arm portion foroperatively engaging a drive member configured to move the plunger armand the plunger head relative to the reservoir body when the arm portionis operatively engaged to the drive member. In some embodiments, thecasing may have an opening for allowing the arm portion of the plungerarm to operatively engage the drive member through the opening.

In various embodiments, the system may further comprise a plurality ofprotuberances positioned on a surface of the plunger arm. Theprotuberances on the surface of the plunger arm may be for contacting aninterior surface of the casing.

In various embodiments, the plunger arm may have a surface havingconcavities and convexities. The convexities on the surface of theplunger arm may be for contacting an interior surface of the casing.

In various embodiments, the system may further comprise a plurality ofprotuberances positioned on an interior surface of the casing. Theprotuberances on the interior surface of the casing may be forcontacting the plunger arm.

In various embodiments, the casing may have an interior surface havingconcavities and convexities. The convexities on the interior surface ofthe casing may be for contacting the plunger arm.

In various embodiments, the system may further comprise a support flangehaving a first side and a second side. The first side of the supportflange may be connected to a side of the plunger arm. The second side ofthe support flange may be connected to a surface of the plunger headthat is operatively connected to the plunger arm.

A method of making a system for transferring fluidic media in accordancewith an embodiment of the present invention may include, but is notlimited to any one or combination of, (i) providing a reservoir bodyhaving an interior volume for containing fluidic media, (ii) locating aplunger head moveable in an axial direction within the reservoir body,(iii) operatively connecting a plunger arm to the plunger head, and (iv)extending a casing from the reservoir body to allow the plunger arm tomove in the axial direction relative to the reservoir body to move theplunger head in the axial direction within the reservoir body.

A system for transferring fluidic media in accordance with an embodimentof the present invention may include, but is not limited to, a reservoirand a plunger head. The reservoir may have an interior volume forcontaining fluidic media. The plunger head may be moveable in an axialdirection within the reservoir. The plunger head may comprise a frontportion and a rear portion. The front portion may be in contact withfluidic media when fluidic media is in the interior volume of thereservoir. The front portion may comprise a first material compatiblewith fluidic media in the interior volume of the reservoir. The rearportion may be located on an opposite side of the plunger head from theinterior volume of the reservoir. The rear portion may be connectable toa plunger arm. The rear portion may comprise a second material differentfrom the first material.

In various embodiments, the system may further comprise a seal memberpositioned between the reservoir and the plunger head. In someembodiments, the seal member may be positioned between the front portionand the rear portion of the plunger head.

In various embodiments, the system may further comprise a connectionstructure that removably attaches the front portion of the plunger headto the rear portion of the plunger head and allows removal of the frontportion of the plunger head from the rear portion of the plunger head.In various embodiments, the second material may be incompatible withfluidic media in the interior volume of the reservoir.

A method of making a system for transferring fluidic media in accordancewith an embodiment of the present invention may include, but is notlimited to any one or combination of, (i) providing a reservoir havingan interior volume for containing fluidic media, and (ii) locating aplunger head moveable in an axial direction within the reservoir, theplunger head comprising a front portion in contact with fluidic mediawhen fluidic media is in the interior volume of the reservoir, the frontportion comprising a first material compatible with fluidic media in theinterior volume of the reservoir and a rear portion located on anopposite side of the plunger head from the interior volume of thereservoir, the rear portion connectable to a plunger arm, the rearportion comprising a second material different from the first material.

A system for transferring fluidic media in accordance with an embodimentof the present invention may include, but is not limited to, a plungerhead, and a seal member. The plunger head may be movable in an axialdirection within a reservoir for containing fluidic media. The sealmember may be arrangeable between the reservoir and the plunger head formovement with the plunger head. The seal member may have a first end anda second end. The first end and the second end of the seal member maytaper to a mid-portion.

In various embodiments, the mid-portion of the seal member may have anarrower dimension relative to each of the first and second ends of theseal member. In various embodiments, the first end and the second end ofthe seal member may be substantially round. In various embodiments, thefirst end and the second end of the seal may be aligned with each otherin the axial direction.

In various embodiments, a space may be formed between the mid-portion ofthe seal member and the reservoir. In further embodiments, the first endand the second end of the seal may be in contact with the reservoir. Inyet further embodiments, the first end and the second end of the sealmay be in contact with the reservoir as the plunger head moves in theaxial direction within the reservoir body.

A method of making a system for transferring fluidic media in accordancewith an embodiment of the present invention may include, but is notlimited to any one or combination of, (i) locating a plunger headmoveable in an axial direction within a reservoir for containing fluidicmedia, and (ii) positioning a seal member between the reservoir and theplunger head for movement with the plunger head, the seal member havinga first end and a second end, the first end and the second end of theseal member tapering to a mid-portion.

A system for transferring fluidic media in accordance with an embodimentof the present invention may include, but is not limited to, a plungerarm and a bias member. The plunger arm may be operatively connectable toa plunger head that is moveable within a reservoir. The plunger arm mayhave an arm portion that is configured for operative engagement to adrive member configured to move the plunger arm and the plunger headwhen the arm portion of the plunger arm is operatively engaged to thedrive member. The bias member may be configured to force the plunger armagainst the drive member to operatively engage the plunger arm to thedrive member.

In various embodiments, the system may further comprise a casingconfigured to support the plunger arm and to envelop at least a portionof the plunger arm. In some embodiments, the bias member may bepositioned between the casing and the plunger arm. In some embodiments,the casing may have an opening for allowing the arm portion of theplunger arm to operatively engage the drive member.

In various embodiments, the system may further comprise an outer casingconfigured to enclose the drive member and at least a portion of theplunger arm. In some embodiments, the bias member may be positionedbetween the outer casing and the plunger arm.

A method of making a system for transferring fluidic media in accordancewith an embodiment of the present invention may include, but is notlimited to any one or combination of, (i) providing a plunger armoperatively connectable to a plunger head that is moveable within areservoir, the plunger arm having an arm portion that is configured foroperative engagement to a drive member configured to move the plungerarm and the plunger head when the arm portion of the plunger arm isoperatively engaged to the drive member and (ii) providing a bias memberconfigured to force the plunger arm against the drive member tooperatively engage the plunger arm to the drive member.

A system for transferring fluidic media may include, but is not limitedto, a plunger head, a seal member, and a plurality of protrusions. Theplunger head may be moveable in an axial direction within a reservoirfor containing fluidic media. The plunger head may have a first ridgeand a second ridge. The seal member may be arranged adjacent at leastone of the first ridge and the second ridge. The seal member may be incontact with the reservoir. The plurality of protrusions may be arrangedaround at least one of the first ridge and the second ridge.

In various embodiments, the protrusions may be for limiting lateralmovement of the plunger head relative to the reservoir. In variousembodiments, the seal member may be arranged between the first ridge andthe second ridge. In various embodiments, the plunger head may have agroove for containing at least a portion of the seal member. In variousembodiments, a space may be provided between each of the protrusions andthe reservoir. In various embodiments, the first ridge and the secondridge may be separate and spaced apart.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a generalized representation of a system inaccordance with an embodiment of the present invention;

FIG. 2 illustrates an example of a system in accordance with anembodiment of the present invention;

FIG. 3 illustrates an example of a delivery device in accordance with anembodiment of the present invention;

FIG. 4 illustrates a delivery device in accordance with an embodiment ofthe present invention;

FIG. 5A illustrates a durable portion of a delivery device in accordancewith an embodiment of the present invention;

FIG. 5B illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 5C illustrates a section view of a durable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6A illustrates a disposable portion of a delivery device inaccordance with an embodiment of the present invention;

FIG. 6B illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIG. 6C illustrates a section view of a disposable portion of a deliverydevice in accordance with an embodiment of the present invention;

FIGS. 7A and 7B illustrate a cross-section of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 8 illustrates an exploded view of a system for transferring fluidicmedia in accordance with an embodiment of the present invention;

FIG. 9A illustrates a cross-section of a portion of a system fortransferring fluidic media in accordance with an embodiment of thepresent invention;

FIG. 9B illustrates a cross-section of a portion of a system fortransferring fluidic media in accordance with an embodiment of thepresent invention;

FIG. 10A illustrates a cross-section of a portion of a system fortransferring fluidic media in accordance with an embodiment of thepresent invention;

FIG. 10B illustrates a cross-section of a portion of a system fortransferring fluidic media in accordance with an embodiment of thepresent invention;

FIG. 11 illustrates a cross-section of a system for transferring fluidicmedia in accordance with an embodiment of the present invention;

FIG. 12 illustrates a cross-section of a system for transferring fluidicmedia in accordance with an embodiment of the present invention;

FIG. 13 illustrates a cross-section of a system for transferring fluidicmedia in accordance with an embodiment of the present invention;

FIG. 14A illustrates a cross-section of a system for transferringfluidic media in accordance with an embodiment of the present invention;

FIG. 14B illustrates a portion of a system for transferring fluidicmedia in accordance with an embodiment of the present invention;

FIG. 15A illustrates a cross-section of a system for transferringfluidic media in accordance with an embodiment of the present invention;and

FIG. 15B illustrates a cross-section of a system for transferringfluidic media in accordance with an embodiment of the present invention.

DETAILED DESCRIPTION

FIG. 1 illustrates a generalized representation of a system 10 inaccordance with an embodiment of the present invention. The system 10includes a delivery device 12. The system 10 may further include asensing device 14, a command control device (CCD) 16, and a computer 18.In various embodiments, the delivery device 12 and the sensing device 14may be secured at desired locations on the body 5 of a patient oruser-patient 7. The locations at which the delivery device 12 and thesensing device 14 are secured to the body 5 of the user-patient 7 inFIG. 1 are provided only as representative, non-limiting, examples.

The system 10, the delivery device 12, the sensing device 14, the CCD16, and computer 18 may be similar to those described in the followingU.S. Patent Applications that were assigned to the assignee of thepresent invention, where each of following patent applications isincorporated herein by reference in its entirety: (i) U.S. patentapplication Ser. No. 11/211,095, filed Aug. 23, 2005, “Infusion DeviceAnd Method With Disposable Portion”; (ii) U.S. patent application Ser.No. 11/515,225, filed Sep. 1, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (iii) U.S.patent application Ser. No. 11/588,875, filed Oct. 27, 2006, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (iv) U.S. patent application Ser. No. 11/588,832, filed Oct.27, 2006, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (v) U.S. patent application Ser. No.11/588,847, filed Oct. 27, 2006, “Infusion Medium Delivery Device AndMethod With Compressible Or Curved Reservoir Or Conduit”; (vi) U.S.patent application Ser. No. 11/589,323, filed Oct. 27, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (vii)U.S. patent application Ser. No. 11/602,173, filed Nov. 20, 2006,“Systems And Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; (viii) U.S. patent application Ser. No. 11/602,052, filedNov. 20, 2006, “Systems And Methods Allowing For Reservoir Filling AndInfusion Medium Delivery”; (ix) U.S. patent application Ser. No.11/602,428, filed Nov. 20, 2006, “Systems And Methods Allowing ForReservoir Filling And Infusion Medium Delivery”; (x) U.S. patentapplication Ser. No. 11/602,113, filed Nov. 20, 2006, “Systems AndMethods Allowing For Reservoir Filling And Infusion Medium Delivery”;(xi) U.S. patent application Ser. No. 11/604,171, filed Nov. 22, 2006,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (xii) U.S. patent application Ser. No.11/604,172, filed Nov. 22, 2006, “Infusion Medium Delivery Device AndMethod With Drive Device For Driving Plunger In Reservoir”; (xiii) U.S.patent application Ser. No. 11/606,703, filed Nov. 30, 2006, “InfusionPumps And Methods And Delivery Devices And Methods With Same”; (xiv)U.S. patent application Ser. No. 11/606,836, filed Nov. 30, 2006,“Infusion Pumps And Methods And Delivery Devices And Methods With Same”;U.S. patent application Ser. No. 11/636,384, filed Dec. 8, 2006,“Infusion Medium Delivery Device And Method With Compressible Or CurvedReservoir Or Conduit”; (xv) U.S. patent application Ser. No. 11/645,993,filed Dec. 26, 2006, “Infusion Medium Delivery Device And Method WithCompressible Or Curved Reservoir Or Conduit”; U.S. patent applicationSer. No. 11/645,972, filed Dec. 26, 2006, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xvi) U.S. patent application Ser. No. 11/646,052,filed Dec. 26, 2006, “Infusion Medium Delivery System, Device And MethodWith Needle Inserter And Needle Inserter Device And Method”; (xvii) U.S.patent application Ser. No. 11/645,435, filed Dec. 26, 2006, “InfusionMedium Delivery System, Device And Method With Needle Inserter AndNeedle Inserter Device And Method”; (xviii) U.S. patent application Ser.No. 11/646,000, filed Dec. 26, 2006, “Infusion Medium Delivery System,Device And Method With Needle Inserter And Needle Inserter Device AndMethod”; (xix) U.S. patent application Ser. No. 11/759,725, filed Jun.7, 2007, “Infusion Medium Delivery Device And Method With Drive DeviceFor Driving Plunger In Reservoir”; (xx) U.S. patent application Ser. No.11/606,837, filed Nov. 30, 2006, “Method And Apparatus For Enhancing TheIntegrity Of An Implantable Sensor Device”; (xxi) U.S. patentapplication Ser. No. 11/702,713, filed Feb. 5, 2007, “Selective PottingFor Controlled Failure And Electronic Devices Employing The Same”;(xxii) U.S. patent application Ser. No. 11/843,601, filed Aug. 22, 2007,“System And Method For Sensor Recalibration”; (xxiii) U.S. patentapplication Ser. No. 11/868,898, filed Oct. 8, 2007, “MultilayerSubstrate”; (xxiv) U.S. patent application Ser. No. 11/964,649, filedDec. 26, 2007, “System And Methods Allowing For Reservoir Air BubbleManagement”; (xxv) U.S. patent application Ser. No. 12/111,751, filedApr. 29, 2008, “Systems And Methods For Reservoir Filling”; (xxvi) U.S.patent application Ser. No. 12/111,815, filed Apr. 29, 2008, “SystemsAnd Methods For Reservoir Air Bubble Management”; (xxvii) U.S. patentapplication Ser. No. 11/924,402, filed Oct. 25, 2007, “Sensor SubstrateAnd Method Of Fabricating Same”; (xxviii) U.S. patent application Ser.No. 11/929,428, filed Oct. 30, 2007, “Telemetry System And Method WithVariable Parameters”; (xxix) U.S. patent application Ser. No.11/965,578, filed Dec. 27, 2007, “Reservoir Pressure EqualizationSystems And Methods”; (xxx) U.S. patent application Ser. No. 12/107,580,filed Apr. 22, 2008, “Automative Filling Systems And Methods”; (xxxi)U.S. patent application Ser. No. 11/964,663, filed Dec. 26, 2007,“Medical Device With Full Options And Selective Enablement/Disablement”;(xxxii) U.S. patent application Ser. No. 10/180,732, filed Jun. 26,2002, “Communication Station And Software For Interfacing With AnInfusion Pump, Analyte Monitor, Analyte Meter, Or The Like”; (xxxiii)U.S. patent application Ser. No. 12/099,738, filed Apr. 8, 2008,“Systems And Methods Allowing For Reservoir Air Bubble Management”;(xxxiv) U.S. patent application Ser. No. 12/027,963, filed Feb. 7, 2008,“Adhesive Patch Systems And Methods”; (xxxv) U.S. patent applicationSer. No. 12/121,647, filed May 15, 2008, “Multi-Lumen Catheter”; (xxxvi)U.S. Patent Provisional Application Ser. No. 61/044,269, filed Apr. 11,2008, “Reservoir Plunger Head Systems And Methods”; (xxxvii) U.S. PatentApplication Ser. No. 61/044,292, filed Apr. 11, 2008, “Reservoir BarrierLayer Systems And Methods”; (xxxviii) U.S. Patent ProvisionalApplication Ser. No. 61/044,322, filed Apr. 11, 2008, “Reservoir SealRetainer Systems And Methods”; (xxxix) U.S. patent application Ser. No.12/179,502, filed Jul. 24, 2008, “Method For Formulating AndImmobilizing A Matrix Protein And A Matrix Protein For Use In A Sensor”;(xl) U.S. patent application Ser. No. 12/336,367, filed Dec. 16, 2008,“Needle Insertions Systems And Methods”; (xli) U.S. patent applicationSer. No. 12/166,210, filed Jul. 1, 2008, “Electronic Device ForControlled Failure”; (xlii) U.S. patent application Ser. No. 12/271,134,filed Nov. 14, 2008, “Multilayer Circuit Devices And ManufacturingMethods Using Electroplated Sacrificial Structures”; (xliii) U.S. patentapplication Ser. No. 12/171,971, filed Jul. 11, 2008, “Infusion MediumDelivery System, Device And Method With Needle Inserter And NeedleInserter Device And Method”; (xliv) U.S. patent application Ser. No.12/189,077, filed Aug. 8, 2008, “Packaging System”; (xlv) U.S. patentapplication Ser. No. 12/179,536, filed Jul. 24, 2008, “Real TimeSelf-Adjusting Calibration Algorithm”; (xlvii) U.S. patent applicationSer. No. 12/277,186, filed Nov. 24, 2008, “Infusion Medium DeliverySystem, Device And Method With Needle Inserter And Needle InserterDevice And Method”; (xlviii) U.S. patent application Ser. No.12/211,783, filed Sep. 16, 2008, “Implantable Sensor Method And System”;(xlix) U.S. patent application Ser. No. 12/247,945, filed Oct. 8, 2008,“Infusion Medium Delivery Device And Method With Drive Device ForDriving Plunger In Reservoir”; (l) U.S. patent application Ser. No.12/360,077, filed Jan. 26, 2009, “Reservoir Barrier Layer Systems AndMethods”; (li) U.S. patent application Ser. No. 12/345,362, filed Dec.29, 2008, “Reservoir Seal Retainer Systems And Methods”; (lii) U.S.patent application Ser. No. 12/353,181, filed Jan. 13, 2009, “SystemsAnd Methods Allowing For Reservoir Filling And Infusion MediumDelivery”; and (liii) U.S. patent application Ser. No. 12/360,813, filedJan. 27, 2009, “Multi-Position Infusion Set Device And Process.” Inother embodiments, the system 10, delivery device 12, sensing device 14,CCD 16, and computer 18 may have other suitable configurations.

The delivery device 12 may be configured to deliver fluidic media to thebody 5 of the user-patient 7. In various embodiments, fluidic media mayinclude a liquid, a fluid, a gel, or the like. In some embodiments,fluidic media may include a medicine or a drug for treating a disease ora medical condition. For example, fluidic media may include insulin fortreating diabetes, or may include a drug for treating pain, cancer, apulmonary disorder, HIV, or the like. In some embodiments, fluidic mediamay include a nutritional supplement, a dye, a tracing medium, a salinemedium, a hydration medium, or the like.

The sensing device 14 may include a sensor, a monitor, or the like, forproviding sensor data or monitor data. In various embodiments, thesensing device 14 may be configured to sense a condition of theuser-patient 7. For example, the sensing device 14 may includeelectronics and enzymes reactive to a biological condition, such as ablood glucose level, or the like, of the user-patient 7.

In various embodiments, the sensing device 14 may be secured to the body5 of the user-patient 7 or embedded in the body 5 of the user-patient 7at a location that is remote from the location at which the deliverydevice 12 is secured to the body 5 of the user-patient 7. In variousother embodiments, the sensing device 14 may be incorporated within thedelivery device 12. In other embodiments, the sensing device 14 may beseparate and apart from the delivery device, and may be, for example,part of the CCD 16. In such embodiments, the sensing device 14 may beconfigured to receive a biological sample, analyte, or the like, tomeasure a condition of the user-patient 7.

In further embodiments, the sensing device 14 and/or the delivery device12 may utilize a closed-loop system. Examples of sensing devices and/ordelivery devices utilizing closed-loop systems may be found at, but arenot limited to, the following references: (i) U.S. Pat. No. 6,088,608,entitled “Electrochemical Sensor And Integrity Tests Therefor”; (ii)U.S. Pat. No. 6,119,028, entitled “Implantable Enzyme-Based MonitoringSystems Having Improved Longevity Due To Improved Exterior Surfaces”;(iii) U.S. Pat. No. 6,589,229, entitled “Implantable Enzyme-BasedMonitoring Systems Adapted for Long Term Use”; (iv) U.S. Pat. No.6,740,072, entitled “System And Method For Providing Closed LoopInfusion Formulation Delivery”; (v) U.S. Pat. No. 6,827,702, entitled“Safety Limits For Closed-Loop Infusion Pump Control”; (vi) U.S. Pat.No. 7,323,142, entitled “Sensor Substrate And Method Of FabricatingSame”; (vii) U.S. patent application Ser. No. 09/360,342, filed Jul. 22,1999, entitled “Substrate Sensor”; and (viii) U.S. Provisional PatentApplication Ser. No. 60/318,060, filed Sep. 7, 2001, entitled “SensingApparatus and Process”, all of which are incorporated herein byreference in their entirety.

In such embodiments, the sensing device 14 may be configured to sense acondition of the user-patient 7, such as, but not limited to, bloodglucose level, or the like. The delivery device 12 may be configured todeliver fluidic media in response to the condition sensed by the sensingdevice 14. In turn, the sensing device 14 may continue to sense a newcondition of the user-patient, allowing the delivery device 12 todeliver fluidic media continuously in response to the new conditionsensed by the sensing device 14 indefinitely. In some embodiments, thesensing device 14 and/or the delivery device 12 may be configured toutilize the closed-loop system only for a portion of the day, forexample only when the user-patient is asleep or awake.

Each of the delivery device 12, the sensing device 14, the CCD 16, andthe computer 18 may include transmitter, receiver, or transceiverelectronics that allow for communication with other components of thesystem 10. The sensing device 14 may be configured to transmit sensordata or monitor data to the delivery device 12. The sensing device 14may also be configured to communicate with the CCD 16. The deliverydevice 12 may include electronics and software that are configured toanalyze sensor data and to deliver fluidic media to the body 5 of theuser-patient 7 based on the sensor data and/or preprogrammed deliveryroutines.

The CCD 16 and the computer 18 may include electronics and othercomponents configured to perform processing, delivery routine storage,and to control the delivery device 12. By including control functions inthe CCD 16 and/or the computer 18, the delivery device 12 may be madewith more simplified electronics. However, in some embodiments, thedelivery device 12 may include all control functions, and may operatewithout the CCD 16 and the computer 18. In various embodiments, the CCD16 may be a portable electronic device. In addition, in variousembodiments, the delivery device 12 and/or the sensing device 14 may beconfigured to transmit data to the CCD 16 and/or the computer 18 fordisplay or processing of the data by the CCD 16 and/or the computer 18.

In some embodiments, the sensing device 14 may be integrated into theCCD 16. Such embodiments may allow the user-patient to monitor acondition by providing, for example, a sample of his or her blood to thesensing device 14 to assess his or her condition. In some embodiments,the sensing device 14 and the CCD 16 may be for determining glucoselevels in the blood and/or body fluids of the user-patient without theuse of, or necessity of, a wire or cable connection between the deliverydevice 12 and the sensing device 14 and/or the CCD 16.

In some embodiments, the CCD 16 may be for providing information to theuser-patient that facilitates the user-patient's subsequent use of adrug delivery system. For example, the CCD 16 may provide information tothe user-patient to allow the user-patient to determine the rate or doseof medication to be administered into the body of the user-patient. Inother embodiments, the CCD 16 may provide information to the deliverydevice 12 to control the rate or dose of medication administered intothe body of the user-patient

Examples of the types of communications and/or control capabilities, aswell as device feature sets and/or program options may be found in thefollowing references: (i) U.S. patent application Ser. No. 10/445,477,filed May 27, 2003, entitled “External Infusion Device with RemoteProgramming, Bolus Estimator and/or Vibration Alarm Capabilities”; (ii)U.S. patent application Ser. No. 10/429,385, filed May 5, 2003, entitled“Handheld Personal Data Assistant (PDA) with a Medical Device and Methodof Using the Same”; and (iii) U.S. patent application Ser. No.09/813,660, filed Mar. 21, 2001, entitled “Control Tabs for InfusionDevices and Methods of Using the Same,” all of which are incorporatedherein by reference in their entirety.

FIG. 2 illustrates an example of the system 10 in accordance with anembodiment of the present invention. The system 10 in accordance withthe embodiment illustrated in FIG. 2 includes the delivery device 12 andthe sensing device 14. The delivery device 12 in accordance with anembodiment of the present invention includes a disposable housing 20, adurable housing 30, and a reservoir system 40. The delivery device 12may further include an infusion path 50.

Elements of the delivery device 12 that ordinarily contact the body of auser-patient or that ordinarily contact fluidic media during operationof the delivery device 12 may be considered as a disposable portion ofthe delivery device 12. For example, a disposable portion of thedelivery device 12 may include the disposable housing 20 and thereservoir system 40. The disposable portion of the delivery device 12may be recommended for disposal after a specified number of uses.

On the other hand, elements of the delivery device 12 that do notordinarily contact the body of the user-patient or fluidic media duringoperation of the delivery device 12 may be considered as a durableportion of the delivery device 12. For example, a durable portion of thedelivery device 12 may include the durable housing 30, electronics (notshown in FIG. 2), a drive device having a motor and drive linkage (notshown in FIG. 2), and the like. Elements of the durable housing portionof the delivery device 12 are typically not contaminated from contactwith the user-patient or fluidic media during normal operation of thedelivery device 12 and, thus, may be retained for re-use with replaceddisposable portions of the delivery device 12.

In various embodiments, the disposable housing 20 supports the reservoirsystem 40 and has a bottom surface (facing downward and into the page inFIG. 2) that is configured to secure to the body of a user-patient. Anadhesive may be employed at an interface between the bottom surface ofthe disposable housing 20 and the skin of a user-patient, to adhere thedisposable housing 20 to the skin of the user-patient. In variousembodiments, the adhesive may be provided on the bottom surface of thedisposable housing 20, with a peelable cover layer covering the adhesivematerial. In this manner, the cover layer may be peeled off to exposethe adhesive material, and the adhesive side of the disposable housing20 may be placed against the user-patient, for example against the skinof the user-patient. Thus in some embodiments, the delivery device 12may be attached to the skin of the user-patient.

In other embodiments, the disposable housing 20 and/or the remainingportions of the delivery device 12 may be worn or otherwise attached onor underneath clothing of the user-patient. Similarly, the deliverydevice 12 may be supported by any suitable manner, such as, but notlimited to, on a belt, in a pocket, and the like. Representativeexamples of such delivery devices 12 may include, but is not limited to,the MiniMed Paradigm 522 Insulin Pump, MiniMed Paradigm 722 InsulinPump, MiniMed Paradigm 515 Insulin Pump, MiniMed Paradigm 715 InsulinPump, MiniMed Paradigm 512R Insulin Pump, MiniMed Paradigm 712R InsulinPump, MiniMed 508 Insulin Pump, MiniMed 508R Insulin Pump, and any otherderivatives thereof.

The reservoir system 40 is configured for containing or holding fluidicmedia, such as, but not limited to insulin. In various embodiments, thereservoir system 40 includes a hollow interior volume for receivingfluidic media, such as, but not limited to, a cylinder-shaped volume, atubular-shaped volume, or the like. In some embodiments, the reservoirsystem 40 may be provided as a cartridge or canister for containingfluidic media. In various embodiments, the reservoir system 40 is ableto be refilled with fluidic media. In further embodiments, the reservoirsystem 40 is pre-filled with fluidic media.

The reservoir system 40 may be supported by the disposable housing 20 inany suitable manner. For example, the disposable housing 20 may beprovided with projections or struts (not shown), or a trough feature(not shown), for holding the reservoir system 40. In some embodiments,the reservoir system 40 may be supported by the disposable housing 20 ina manner that allows the reservoir system 40 to be removed from thedisposable housing 20 and replaced with another reservoir.Alternatively, or in addition, the reservoir system 40 may be secured tothe disposable housing 20 by a suitable adhesive, a strap, or othercoupling structure.

In various embodiments, the reservoir system 40 includes a port 41 forallowing fluidic media to flow into and/or flow out of the interiorvolume of the reservoir system 40. In some embodiments, the infusionpath 50 includes a connector 56, a tube 54, and a needle apparatus 52.The connector 56 of the infusion path 50 may be connectable to the port41 of the reservoir system 40. In various embodiments, the disposablehousing 20 is configured with an opening near the port 41 of thereservoir system 40 for allowing the connector 56 of the infusion path50 to be selectively connected to and disconnected from the port 41 ofthe reservoir system 40.

In various embodiments, the port 41 of the reservoir system 40 iscovered with or supports a septum (not shown in FIG. 2), such as aself-sealing septum, or the like. The septum may be configured toprevent fluidic media from flowing out of the reservoir system 40through the port 41 when the septum is not pierced. In addition, invarious embodiments, the connector 56 of the infusion path 50 includes aneedle for piercing the septum covering the port 41 of the reservoirsystem 40 to allow fluidic media to flow out of the interior volume ofthe reservoir system 40.

Examples of needle/septum connectors can be found in U.S. patentapplication Ser. No. 10/328,393, filed Dec. 22, 2003, entitled“Reservoir Connector,” which is incorporated herein by reference in itsentirety. In other alternatives, non-septum connectors such as Luerlocks, or the like may be used. In various embodiments, the needleapparatus 52 of the infusion path 50 includes a needle that is able topuncture the skin of a user-patient. In addition, in variousembodiments, the tube 54 connects the connector 56 with the needleapparatus 52 and is hollow, such that the infusion path 50 is able toprovide a path to allow for the delivery of fluidic media from thereservoir system 40 to the body of a user-patient.

The durable housing 30 of the delivery device 12 in accordance withvarious embodiments of the present invention includes a housing shellconfigured to mate with and secure to the disposable housing 20. Thedurable housing 30 and the disposable housing 20 may be provided withcorrespondingly shaped grooves, notches, tabs, or other suitablefeatures, that allow the two parts to easily connect together, bymanually pressing the two housings together, by twist or threadedconnection, or other suitable manner of connecting the parts that iswell known in the mechanical arts.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be connected to each other using a twist action. Thedurable housing 30 and the disposable housing 20 may be configured to beseparable from each other when a sufficient force is applied todisconnect the two housings from each other. For example, in someembodiments the disposable housing 20 and the durable housing 30 may besnapped together by friction fitting. In various embodiments, a suitableseal, such as an o-ring seal, may be placed along a peripheral edge ofthe durable housing 30 and/or the disposable housing 20 to provide aseal against water entering between the durable housing 30 and thedisposable housing 20.

The durable housing 30 of the delivery device 12 may support a drivedevice (not shown in FIG. 2) that may include a motor and a drive devicelinkage portion. The drive device may be for applying a force to fluidicmedia within the reservoir system 40 to force fluidic media out of thereservoir system 40 and into an infusion path, such as the infusion path50, for delivery to a user-patient. For example, in some embodiments, anelectrically driven motor may be mounted within the durable housing 30with appropriate linkage for operatively coupling the motor to a plungerarm (not shown in FIG. 2) connected to a plunger head (not shown in FIG.2) within the reservoir system 40. The electrically driven motor maydrive the plunger head in a direction to force fluidic media out of theport 41 of the reservoir system 40 and to the user-patient.

Also, in some embodiments, the motor may be controllable to reversedirection to move the plunger arm and the plunger head to cause fluid tobe drawn into the reservoir system 40 from a patient. The motor may bearranged within the durable housing 30 and the reservoir system 40 maybe correspondingly arranged on the disposable housing 20, such that theoperable engagement of the motor with the plunger head, through theappropriate linkage, occurs automatically upon the user-patientconnecting the durable housing 30 with the disposable housing 20 of thedelivery device 12. Further examples of linkage and control structuresmay be found in U.S. patent application Ser. No. 09/813,660, filed Mar.21, 2001, entitled “Control Tabs for Infusion Devices and Methods ofUsing the Same”, which is incorporated herein by reference in itsentirety.

In various embodiments, the durable housing 30 and the disposablehousing 20 may be made of suitably rigid materials that maintain theirshape, yet provide sufficient flexibility and resilience to effectivelyconnect together and disconnect, as described above. The material of thedisposable housing 20 may be selected for suitable compatibility withskin. For example, the disposable housing 20 and the durable housing 30of the delivery device 12 may be made of any suitable plastic, metal,composite material, or the like. The disposable housing 20 may be madeof the same type of material or a different material relative to thedurable housing 30. In some embodiments, the disposable housing 20 andthe durable housing 30 may be manufactured by injection molding or othermolding processes, machining processes, or combinations thereof.

For example, the disposable housing 20 may be made of a relativelyflexible material, such as a flexible silicone, plastic, rubber,synthetic rubber, or the like. By forming the disposable housing 20 of amaterial capable of flexing with the skin of a user-patient, a greaterlevel of user-patient comfort may be achieved when the disposablehousing 20 is secured to the skin of the user-patient. In addition, aflexible disposable housing 20 may result in an increase in site optionson the body of the user-patient at which the disposable housing 20 maybe secured.

In the embodiment illustrated in FIG. 2, the delivery device 12 isconnected to the sensing device 14 through a connection element 17 ofthe sensing device 14. The sensing device 14 may include a sensor 15that includes any suitable biological or environmental sensing device,depending upon a nature of a treatment to be administered by thedelivery device 12. For example, in the context of delivering insulin toa diabetes patient, the sensor 15 may include a blood glucose sensor, orthe like.

In some embodiments, the sensor 15 may include a continuous glucosesensor. The continuous glucose sensor may be implantable within the bodyof the user-patient. In other embodiments, the continuous glucose sensormay be located externally, for example on the skin of the user-patient,or attached to clothing of the user-patient. In such embodiments, fluidmay be drawn continually from the user-patient and sensed by thecontinuous glucose sensor. In various embodiments, the continuousglucose sensor may be configured to sense and/or communicate with theCCD 16 continuously. In other embodiments, the continuous glucose sensormay be configured to sense and/or communicate with the CCD 16intermittently, for example sense glucose levels and transmitinformation every few minutes. In various embodiments, the continuousglucose sensor may utilize glucose oxidase.

The sensor 15 may be an external sensor that secures to the skin of auser-patient or, in other embodiments, may be an implantable sensor thatis located in an implant site within the body of the user-patient. Infurther alternatives, the sensor may be included with as a part or alongside the infusion cannula and/or needle, such as for example as shown inU.S. patent application Ser. No. 11/149,119, filed Jun. 8, 2005,entitled “Dual Insertion Set”, which is incorporated herein by referencein its entirety. In the illustrated example of FIG. 2, the sensor 15 isan external sensor having a disposable needle pad that includes a needlefor piercing the skin of the user-patient and enzymes and/or electronicsreactive to a biological condition, such as blood glucose level or thelike, of the user-patient. In this manner, the delivery device 12 may beprovided with sensor data from the sensor 15 secured to the user-patientat a site remote from the location at which the delivery device 12 issecured to the user-patient.

While the embodiment shown in FIG. 2 includes a sensor 15 connected bythe connection element 17 for providing sensor data to sensorelectronics (not shown in FIG. 2) located within the durable housing 30of the delivery device 12, other embodiments may employ a sensor 15located within the delivery device 12. Yet other embodiments may employa sensor 15 having a transmitter for communicating sensor data by awireless communication link with receiver electronics (not shown in FIG.2) located within the durable housing 30 of the delivery device 12. Invarious embodiments, a wireless connection between the sensor 15 and thereceiver electronics within the durable housing 30 of the deliverydevice 12 may include a radio frequency (RF) connection, an opticalconnection, or another suitable wireless communication link. Furtherembodiments need not employ the sensing device 14 and, instead, mayprovide fluidic media delivery functions without the use of sensor data.

As described above, by separating disposable elements of the deliverydevice 12 from durable elements, the disposable elements may be arrangedon the disposable housing 20, while durable elements may be arrangedwithin a separable durable housing 30. In this regard, after aprescribed number of uses of the delivery device 12, the disposablehousing 20 may be separated from the durable housing 30, so that thedisposable housing 20 may be disposed of in a proper manner. The durablehousing 30 may then be mated with a new (un-used) disposable housing 20for further delivery operation with a user-patient.

FIG. 3 illustrates an example of the delivery device 12 in accordancewith another embodiment of the present invention. The delivery device 12of the embodiment of FIG. 3 is similar to the delivery device 12 of theembodiment of FIG. 2. While the delivery device 12 in the embodimentillustrated in FIG. 2 provides for the durable housing 30 to cover thereservoir system 40, the delivery device 12 in the embodiment of FIG. 3provides for the durable housing 30 to secure to the disposable housing20 without covering the reservoir system 40. The delivery device 12 ofthe embodiment illustrated in FIG. 3 includes the disposable housing 20,and the disposable housing 20 in accordance with the embodimentillustrated in FIG. 3 includes a base 21 and a reservoir retainingportion 24. In one embodiment, the base 21 and reservoir retainingportion 24 may be formed as a single, unitary structure.

The base 21 of the disposable housing 20 is configured to be secured tothe body of a user-patient. The reservoir-retaining portion 24 of thedisposable housing 20 is configured to house the reservoir system 40.The reservoir-retaining portion 24 of the disposable housing 20 may beconfigured to have an opening to allow for the port 41 of the reservoirsystem 40 to be accessed from outside of the reservoir-retaining portion24 while the reservoir system 40 is housed in the reservoir-retainingportion 24. The durable housing 30 may be configured to be attachable toand detachable from the base 21 of the disposable housing 20. Thedelivery device 12 in the embodiment illustrated in FIG. 3 includes aplunger arm 60 that is connected to or that is connectable to a plungerhead (not shown in FIG. 3) within the reservoir system 40.

FIG. 4 illustrates another view of the delivery device 12 of theembodiment of FIG. 3. The delivery device 12 of the embodimentillustrated in FIG. 4 includes the disposable housing 20, the durablehousing 30, and the infusion path 50. The disposable housing 20 in theembodiment of FIG. 4 includes the base 21, the reservoir-retainingportion 24, and a peelable cover layer 25. The peelable cover layer 25may cover an adhesive material on the bottom surface 22 of the base 21.The peelable cover layer 25 may be configured to be peelable by auser-patient to expose the adhesive material on the bottom surface 22 ofthe base 21. In some embodiments, there may be multiple adhesive layerson the bottom surface 22 of the base 21 that are separated by peelablelayers.

The infusion path 50 in accordance with the embodiment of the presentinvention illustrated in FIG. 4 includes the needle 58 rather than theconnector 56, the tube 54, and the needle apparatus 52 as shown in theembodiment of FIG. 2. The base 21 of the disposable housing 20 may beprovided with an opening or pierceable wall in alignment with a tip ofthe needle 58, to allow the needle 58 to pass through the base 21 andinto the skin of a user-patient under the base 21, when extended. Inthis manner, the needle 58 may be used to pierce the skin of theuser-patient and deliver fluidic media to the user-patient.

Alternatively, the needle 58 may be extended through a hollow cannula(not shown in FIG. 4), such that upon piercing the skin of theuser-patient with the needle 58, an end of the hollow cannula is guidedthrough the skin of the user-patient by the needle 58. Thereafter, theneedle 58 may be removed; leaving the hollow cannula in place with oneend of the cannula located within the body of the user-patient and theother end of the cannula in fluid flow connection with fluidic mediawithin the reservoir system 40. Accordingly, fluidic media may beconveyed from the reservoir system 40 to the body of the user-patient.

FIG. 5A illustrates a durable portion 8 of the delivery device 12 (referto FIG. 3) in accordance with an embodiment of the present invention.FIG. 5B illustrates a section view of the durable portion 8 inaccordance with an embodiment of the present invention. FIG. 5Cillustrates another section view of the durable portion 8 in accordancewith an embodiment of the present invention. With reference to FIGS. 5A,5B, and 5C, in various embodiments, the durable portion 8 includes thedurable housing 30, and a drive device 80. The drive device 80 includesa motor 84 and a drive device linkage portion 82.

In various embodiments, the durable housing 30 may include an interiorvolume for housing the motor 84, the drive device linkage portion 82,other electronic circuitry, and a power source (not shown in FIGS. 5A,5B, and 5C). In addition, in various embodiments, the durable housing 30is configured with an opening 32 for receiving a plunger arm 60 (referto FIG. 3). In addition, in various embodiments, the durable housing 30may include one or more connection members 34, such as tabs, insertionholes, or the like, for connecting with the base 21 of the disposablehousing 20 (refer to FIG. 3).

FIG. 6A illustrates a disposable portion 9 of the delivery device 12(refer to FIG. 3) in accordance with an embodiment of the presentinvention. FIG. 6B illustrates a section view of the disposable portion9 in accordance with an embodiment of the present invention. FIG. 6Cillustrates another section view of the disposable portion 9 inaccordance with an embodiment of the present invention. With referenceto FIGS. 6A, 6B, and 6C, in various embodiments, the disposable portion9 includes the disposable housing 20, the reservoir system 40, theplunger arm 60, and a plunger head 70. In some embodiments, thedisposable housing 20 includes the base 21 and the reservoir-retainingportion 24. In various embodiments, the base 21 includes a top surface23 having one or more connection members 26, such as tabs, grooves, orthe like, for allowing connections with the one or more connectionmembers 34 of embodiments of the durable housing 30 (refer to FIG. 5B).

In various embodiments, the reservoir system 40 is housed within thereservoir retaining portion 24 of the disposable housing 20, and thereservoir system 40 is configured to hold fluidic media. In addition, invarious embodiments, the plunger head 70 is disposed at least partiallywithin the reservoir system 40 and is moveable within the reservoirsystem 40 to allow fluidic media to fill into the reservoir system 40and to force fluidic media out of the reservoir system 40. In someembodiments, the plunger arm 60 is connected to or is connectable to theplunger head 70.

Also, in some embodiments, a portion of the plunger arm 60 extends tooutside of the reservoir-retaining portion 24 of the disposable housing20. In various embodiments, the plunger arm 60 has a mating portion formating with the drive device linkage portion 82 of the drive device 80(refer to FIG. 5C). With reference to FIGS. 5C and 6C, in someembodiments, the durable housing 30 may be snap fitted onto thedisposable housing 20, whereupon the drive device linkage portion 82automatically engages the mating portion of the plunger arm 60.

After the durable housing 30 and the disposable housing 20 are fittedtogether with the drive device linkage portion 82 engaging or matingwith the plunger arm 60, the motor 84 may be controlled to drive thedrive device linkage portion 82 and, thus, move the plunger arm 60 tocause the plunger head 70 to move within the reservoir system 40. Whenthe interior volume of the reservoir system 40 is filled with fluidicmedia and an infusion path is provided from the reservoir system 40 tothe body of a user-patient, the plunger head 70 may be moved within thereservoir system 40 to force fluidic media from the reservoir system 40and into the infusion path to deliver fluidic media to the body of theuser-patient.

In various embodiments, once the reservoir system 40 has beensufficiently emptied or otherwise requires replacement, a user-patientmay simply remove the durable housing 30 from the disposable housing 20,and replace the disposable portion 9, including the reservoir system 40,with a new disposable portion having a new reservoir. The durablehousing 30 may be connected to the new disposable housing of the newdisposable portion, and the delivery device including the new disposableportion may be secured to the skin of a user-patient, or otherwiseattached to the user-patient.

In various other embodiments, rather than replacing the entiredisposable portion 9 every time the reservoir system 40 is emptied, thereservoir system 40 may be refilled with fluidic media. In someembodiments, the reservoir system 40 may be refilled while remainingwithin the reservoir retaining portion 24 (refer to FIG. 6B) of thedisposable housing 20. In addition, in various embodiments, thereservoir system 40 may be replaced with a new reservoir (not shown),while the disposable housing 20 may be re-used with the new reservoir.In such embodiments, the new reservoir may be inserted into thedisposable portion 9.

With reference to FIGS. 3, 5A, 6B, and 6C, in various embodiments, thedelivery device 12 includes reservoir status circuitry (not shown), andthe reservoir system 40 includes reservoir circuitry (not shown). Invarious embodiments, the reservoir circuitry stores information such as,but not limited to, at least one of (i) an identification stringidentifying the reservoir system 40; (ii) a manufacturer of thereservoir system 40; (iii) contents of the reservoir system 40; and (iv)an amount of contents in the reservoir system 40. In some embodiments,the delivery device 12 includes the reservoir status circuitry (notshown), and the reservoir status circuitry is configured to read datafrom the reservoir circuitry when the reservoir system 40 is insertedinto the disposable portion 9.

In various embodiments, the reservoir status circuitry may be furtherconfigured to store data to the reservoir circuitry after at least someof the contents of the reservoir system 40 have been transferred out ofthe reservoir system 40 to update information in the reservoir circuitryrelated to an amount of contents still remaining in the reservoir system40. In some embodiments, the reservoir status circuitry is configured tostore data to the reservoir circuitry, to update information in thereservoir circuitry related to an amount of contents remaining in thereservoir system 40, when the reservoir system 40 is inserted into thedisposable portion 9. In some embodiments, the delivery device 12includes the reservoir status circuitry (not shown) and the reservoirsystem 40 includes the reservoir circuitry (not shown), and thereservoir status circuitry selectively inhibits use of the deliverydevice 12 or selectively provides a warning signal based on informationread by the reservoir status circuitry from the reservoir circuitry.

FIGS. 7-12 illustrate a reservoir system 100 that may be employed as anembodiment of the reservoir system 40 discussed above, for deliveringfluidic media in accordance with an embodiment of the present invention.Although the reservoir system 100 may be similar or used with theembodiments of FIGS. 1-6C, it should be understood that the reservoirsystem 100 may also include some or all of the same components andoperate in a manner similar to that shown and described in theembodiments of FIGS. 13-15B. In addition, some or all of the featuresshown in FIGS. 1-6C and 13-15B may be combined in various ways andincluded in the embodiment shown in FIGS. 7-12. The reservoir system 100may include, but is not limited to, a container or body 110 of thereservoir, a plunger head 120, a plunger arm 126, and a plunger armcasing 130.

The reservoir body 110 may have an interior volume 112 for containingfluidic media. The reservoir body 110 may have a first port 114 forallowing fluidic media to flow into the interior volume 112 of thereservoir body 110. The reservoir body 110 may have a second port 116for expelling fluidic media contained in the interior volume 112 of thereservoir body 110. In various embodiments, one of the first port 114and the second port 116 of the reservoir body 110 may be for allowingfluidic media to flow into the interior volume 112 of the reservoir body110 and for expelling fluidic media contained in the interior volume 112of the reservoir body 110. In various embodiments, the reservoir body110 may be made of various suitable materials, including, but notlimited to, glass, plastic, TOPAS® polymers (or any other cyclic olefincopolymer (or polymer)), or the like.

The plunger head 120 may be located within the reservoir body 110 andmay be moveable in an axial direction of the reservoir body 110 toexpand (e.g., FIG. 7A) or contract (e.g., FIG. 7B) the interior volume112 of the reservoir body 110. The plunger head 120 may be advancedwithin the reservoir body 110 to expel fluidic media contained in theinterior volume 112 of the reservoir body 110 out the second port 116 ofthe reservoir body 110. The plunger head 120 may be made of Bromobutylrubber, silicone rubber, or any other suitable material and/or anyderivative thereof. The plunger head 120 may have a front portion 122and a rear portion 123.

The front portion 122 of the plunger head 120 may be in contact withfluidic media contained in the interior volume 112 of the reservoir body110. In some embodiments, the front portion 122 of the plunger head 120may comprise a material compatible with fluidic media contained in theinterior volume 112 of the reservoir body 110. In such embodiments, anynumber of the remaining portions of the plunger head 120, such as therear portion 123 of the plunger head 120, the plunger arm 126, and theplunger arm casing 130 may be made of a similar material or of anysuitable material, including, but not limited to, materials that neednot be compatible with fluidic media contained in the interior volume112 of the reservoir body 110. Such materials may be selected based onstrength, cost, or the like.

In some embodiments, where the interior volume 112 of the reservoir body110 is for containing insulin, the front portion 122 of the plunger head120 may comprise an insulin compatible material, such as, but notlimited to, polyethylene, or the like. In such embodiments, any numberof the remaining portions of the plunger head 120, such as the rearportion 123 of the plunger head 120, the plunger arm 126, and theplunger arm casing 130, may be made of an insulin compatible material,which may be the same or different from that of the front portion 122,or of any suitable material, including, but not limited to, materialsthat need not be compatible with insulin.

In some embodiments, the front portion 122 of the plunger head 120 maybe removably attachable to the plunger head 120 (or the rear portion123). For example, the front portion 122 of the plunger head 120 mayhave one or more tabs 121 configured to fit into one or more apertures(not shown) located on the plunger head 120. Alternatively, the frontportion 122 of the plunger head 120 may have one or more apertures (notshown) for receiving one or more tabs (not shown) provided on theplunger head 120 (or the rear portion 123). In various embodiments, thefront portion 122 of the plunger head 120 may be secured to the plungerhead 120 in any suitable manner, such as, but not limited to, asnap-fitting, an adhesive, friction fitting, laser welding, magneticcoupling, or the like.

The rear portion 123 of the plunger head 120 may be connected orconnectable to an end of the plunger arm 126 in any suitable manner. Forexample, the rear portion 123 of the plunger head 120 may include anaperture (not shown) for receiving a tab (not shown) or the like of theplunger arm 126. The tab (not shown) may be snap-fit into the aperture(not shown) to connect the plunger arm 126 to the rear portion 123 ofthe plunger head 120. Alternatively, the rear portion 123 of the plungerhead 120 may have one or more tabs (not shown) configured to fit intoone or more apertures (not shown) located on the plunger arm 126. Invarious other embodiments, the plunger arm 126 may be connected to theplunger head 120 and/or the rear portion 123 of the plunger head 120 inany suitable manner, such as, but not limited to, an adhesive, frictionfitting, laser welding, magnetic coupling, or the like.

The plunger arm 126 may be moveable in an axial direction within theplunger arm casing 130 and the reservoir body 110. In some embodiments,the plunger arm 126 and the rear portion 123 of the plunger head 120 maybe integral to one another. In other embodiments, the plunger arm 126and the rear portion 123 of the plunger head 120 may be separatecomponents.

The plunger arm 126 may include an engagement side 128 for operativelyengaging a drive member 140, drive linkage, or the like. For example,the engagement side 128 of the plunger arm 126 and the drive member 140may be complementing gears, complementing threaded members, or the like,that may operatively engage one another. The drive member 140 may be adrive screw, drive rack, or the like. The drive member 140 may beconnected to a motor (not shown) to move the drive member 140 to causethe plunger arm 126 to move within the plunger arm casing 130 and thereservoir body 110. Accordingly, the drive motor may actuate the plungerarm 126 to move within the reservoir body 110 to expand and contact theinterior volume 112 of the reservoir body 110.

The plunger arm casing 130 may be for supporting the plunger arm 126 asthe plunger arm 126 is moved along the plunger arm casing 130. At leastone side of the plunger arm 126 may be in contact with one or moreinterior sides of the plunger arm casing 130. In some embodiments, theplunger arm casing 130 may be for aligning the plunger arm 126 as theplunger arm 126 is moved along the reservoir body 110, for example bythe drive member 140. The plunger arm casing 130 may ensure linearalignment of the plunger arm 126 relative to the longitudinal axis ofthe reservoir body 110 and/or perpendicularity of the plunger head 120relative to the reservoir body 110 as the plunger arm 126 and/or theplunger head 120 enters and/or moves within the reservoir body 110.

In various embodiments, the plunger arm casing 130 may be sized andconfigured to substantially envelop the plunger arm 126, for example ina case where the plunger head 120 is in a position substantially nearthe back end of the reservoir body 110 (e.g., FIG. 7A). Accordingly, theplunger head 120 may be moveable from that position toward a front endof the reservoir body 110 (e.g., FIG. 7B) in which case a portion of theplunger arm 126 may be located within the reservoir body 110 and afurther portion of the plunger arm 126 may be located within the plungerarm casing 130. Thus in some embodiments, the plunger arm 126 may belocated within the reservoir body 110 and/or the plunger arm casing 130during use of the reservoir system 100 by the user-patient (e.g., duringdelivery of fluidic media to the user-patient).

With reference to FIGS. 7A, 7B, and 8, in some embodiments, the plungerarm casing 130 may have a feature such as an opening 136 for allowing aportion of the engagement side 128 of the plunger arm 126 to operativelyengage the drive member 140. In such embodiments, the plunger arm 126may be surrounded by the plunger arm casing 130 and/or the reservoirbody 110. Accordingly in such embodiments, only the portion of theengagement side 128 of the plunger arm 126 exposed by the opening 136may be free from (i.e., not covered by) the plunger arm casing 130and/or the reservoir body 110 for operable engagement with the drivemember 140. This may allow the drive member 140 to operatively engagethe engagement side 128 of the plunger arm 126 while the plunger arm 126or a portion thereof remains in the plunger arm casing 130 and/or thereservoir body 110.

The reservoir system 100 may include a reservoir cover (or casing) 134that may be sized and configured to cover an end 117 of the reservoirbody 110. For example, in a case where the first port 114 and the secondport 116 is located on a first end of the reservoir body 110, a secondend opposite the first end may be the end 117 of the reservoir body 110covered by the reservoir cover 134. The reservoir cover 134 may beintegral with the plunger arm casing 130.

In other embodiments, the reservoir cover 134 may be separate from theplunger arm casing 130. For example, the reservoir cover 134 may beremovably attachable to the plunger arm casing 130. In such embodiments,the reservoir cover 134 may be connected to or connectable to theplunger arm casing 130 in any suitable manner, such as those previouslydescribed.

In some embodiments, the end 117 of the reservoir body 110 may be open.The reservoir cover 134 may cover the open end 117 of the reservoir body110 or be configured to fit within the open end 117 of the reservoirbody 110 to seal or close the open end 117 of the reservoir body 110.The open end 117 may allow the plunger head 120 and/or at least aportion of the plunger arm 126 attached to the plunger head 120 to beinsertable into the reservoir body 110, for example, before thereservoir cover 134 is placed in/on the reservoir body 110 to cover theopen end 117 of the reservoir body 110.

For example, the reservoir cover 134 may include one or more tabs 138sized and configured to fit within one or more recesses 118 on end 117of the reservoir body 110, to fit the reservoir cover 134 to thereservoir body 110, to substantially close the reservoir body 110 afterthe plunger head 120 and/or at least a portion of the plunger arm 126have been placed in the reservoir body 110. Alternatively, the reservoircover 134 may include one or more recesses (not shown) for receiving oneor more tabs (not shown) of the reservoir body 110 to fit the reservoircover 134 to the reservoir body 110. However, the reservoir cover 134may be connected to or connectable to the reservoir body in any suitablemanner, such as those previously described.

In some embodiments, the reservoir cover 134 and/or the plunger armcasing 130 may be configured for minimizing an expansion of thereservoir body 110, for example, as pressure within the reservoir body110 increases during use. In such embodiments, by fitting the reservoircover 134 to the back of the reservoir body 110 in one or moredimensions, the reservoir cover 134 may help to retain a shape of thereservoir body 110.

A seal member 124 (524 in FIG. 13), such as an o-ring or the like, maybe positioned between the reservoir body 110 and a portion of theplunger head 120. The interior volume 112 of the reservoir body 110 maybe on one side of the seal member 124. The reservoir body 110 may have achamber 152 located on an opposite side of the seal member 124 from theinterior volume 112 of the reservoir body 110.

The seal member 124 may be for substantially preventing fluidic mediafrom flowing from the interior volume 112 of the reservoir body 110 tothe chamber 152 of the reservoir body 110. The chamber 152 of thereservoir body 110 may be located between the seal member 124 and thereservoir cover 134 in a case where the plunger head 120 is in thereservoir body 110 and the reservoir cover 134 and/or the plunger armcasing 130 are fitted or otherwise attached to the reservoir body 110.In some embodiments, the seal member 124 may be located between thefront portion 122 and the rear portion 123 of the plunger head 120.

In some embodiments, the reservoir system 100 may include at least onesupport flange 127 positioned on the plunger arm 126 and the rearportion 123 of the plunger head 120. The support flange 127 may provideadditional structural strength to the plunger arm 126 and/or the plungerhead 120. For example, the support flange 127 may have a triangularconfiguration and be positioned with one side of the support flange 127connected to a top surface of the plunger arm 126 and a second side ofthe support flange 127 connected to the rear portion 123 of the plungerhead 120. In addition or alternatively, a second support flange (notshown) may be positioned with one side of the second support flange (notshown) connected to a side surface of the plunger arm 126 and a secondside of the second support flange (not shown) connected to the rearportion 123 of the plunger head 120.

In some embodiments, such as the embodiment illustrated in FIG. 9A, atleast one of the one or more interior sides of the plunger arm casing130 may include a plurality of protuberances 139 for contacting at leastone side of the plunger arm 126. In other embodiments, such as theembodiment illustrated in FIG. 9B, the interior side of the plunger armcasing 130 may have a plurality of concavities and convexities 137. Theconvexities 137 may be for contacting at least one side of the plungerarm 126.

In some embodiments, such as the embodiment illustrated in FIG. 10A, theplunger arm 126 may have a plurality of protuberances 129 for contactingat least one interior side of the plunger arm casing (not shown) when atleast a portion of the plunger arm 126 is in the plunger arm casing 130.In other embodiments, such as the embodiment illustrated in FIG. 10B,the plunger arm 126 may have a plurality of concavities and convexities129. The convexities 129 may be for contacting at least one interiorside of the plunger arm casing 130.

In some embodiments, such as the embodiment illustrated in FIG. 11, thereservoir system 100 may include a bias member 153. The bias member 153may comprise, but is not limited to, a spring or the like. The biasmember 153 may be positioned between the plunger arm casing 130 and theplunger arm 126. The bias member 153 may be configured to force theplunger arm 126 against the drive member 140 to allow the plunger arm126 to operatively engage the drive 140.

In other embodiments, such as the embodiment illustrated in FIG. 12, thereservoir system 100 may include an outer casing 190 and a bias member154. The outer casing 190 may be for enclosing at least a portion of thedrive member 140 and at least a portion of the plunger arm 126. Invarious embodiments, the outer casing 190 may also enclose other drivecomponents or portions thereof, such as, a drive motor (not shown)and/or other drive member(s)/linkage operatively connecting the drivemember 140 and the drive motor (not shown).

The outer casing 190 be sized and configured to cover an end 117 of thereservoir body 110. For example, in a case where the first port 114 andthe second port 116 is located on a first end of the reservoir body 110,a second end opposite the first end may be the end 117 of the reservoirbody 110 covered by the reservoir cover 134. The outer casing 190 maycover the open end of the reservoir body 110 or have a portion adaptedto fit within the open end of the reservoir body 110 to seal or closethe open end of the reservoir body 110. In other embodiments, the outercasing 190 may be removably attachable to the plunger arm casing 130.

In some embodiments, the end 117 of the reservoir body 110 may be open.The outer casing 190 may cover the open end 117 of the reservoir body110 or be configured to fit within the open end 117 of the reservoirbody 110 to seal or close the open end 117 of the reservoir body 110.The open end 117 may allow the plunger head 120 and/or at least aportion of the plunger arm 126 attached to the plunger head 120 to beinsertable into the reservoir body 110, for example, before the outercasing 190 is placed in/on the reservoir body 110 to cover the open end117 of the reservoir body 110.

For example, the outer casing 190 may include one or more tabs 138 sizedand configured to fit within one or more recesses 118 on end 117 of thereservoir body 110, to fit the outer casing 190 to the reservoir body110, to substantially close the reservoir body 110 after the plungerhead 120 and/or at least a portion of the plunger arm 126 have beenplaced in the reservoir body 110. Alternatively, the outer casing 190may include one or more recesses (not shown) for receiving one or moretabs (not shown) of the reservoir body 110 to fit the outer casing 190to the reservoir body 110. However, the outer casing 190 may beconnected to or connectable to the reservoir body 110 in any suitablemanner, such as those previously described.

The bias member 154 may comprise, but is not limited to, a spring or thelike. The bias member 154 may be positioned between the outer casing 190and the plunger arm 126. The bias member 154 may be configured to forcethe plunger arm 126 against the drive member 140 to allow the plungerarm 126 to operatively engage the drive 140.

In some embodiments, the reservoir system 100 may include a plunger armcasing (not shown) that may have an opening 136 for allowing a portionof the engagement side 128 of the plunger arm 126 to operatively engagethe drive member 140. In such embodiments, the plunger arm 126 may becompletely surrounded by the plunger arm casing (not shown) and/or thereservoir body 110. Accordingly, only the portion of the engagement side128 of the plunger arm 126 exposed by the opening 136 may not be coveredby the plunger arm casing (not shown) and/or the reservoir body 110,thus allowing the drive member 140 to operatively engage the engagementside 128 of the plunger arm 126. In further embodiments, the plunger armcasing (not shown) may be adapted to allow the bias member 154 tocontact the plunger arm 126. For example, the plunger arm casing (notshown) may include a second opening for allowing the bias member 154 tocontact the plunger arm 126.

In some embodiments, the outer casing 190 and/or the plunger arm casing130 may be configured for minimizing an expansion of the reservoir body110, for example, as pressure within the reservoir body 110 increasesduring use. In such embodiments, by fitting the outer casing 190 to theback of the reservoir body 110 in one or more dimensions, the outercasing 190 may help to retain a shape of the reservoir body 110.

In various embodiments where the reservoir system 100 is pre-filled withfluidic media, the reservoir 110 may include a plunger head (e.g., 120)that may be attachable to the delivery device (not shown) as describedabove. In other embodiments, the plunger head may be placed in thereservoir 110 before or after the reservoir 110 is filled with fluidicmedia.

FIG. 13 illustrates a reservoir system 500 that may be employed as anembodiment of the reservoir system 40 discussed above, for deliveringfluidic media in accordance with an embodiment of the present invention.Although the reservoir system 500 may be similar or used with theembodiments of FIGS. 7-12, it should be understood that the reservoirsystem 500 may also include some or all of the same components andoperate in a manner similar to that shown and described in theembodiments of FIGS. 1-6C and 13-15B. In addition, some or all of thefeatures shown in FIGS. 1-12 and 13-15B may be combined in various waysand included in the embodiment shown in FIG. 13. The reservoir system500 may include, but is not limited to, a reservoir 510, a plunger head520, a plunger arm 526, and a seal member 524.

The reservoir 510 may have an interior volume 512 for containing fluidicmedia. The reservoir 510 may have a port 516 for expelling fluidic mediacontained in the interior volume 512 of the reservoir 510. In variousembodiments, the reservoir 510 may be made of various suitablematerials, including, but not limited to, glass, plastic, TOPAS®polymers (or any other cyclic olefin copolymer (or polymer)), or thelike.

The plunger head 520 may be located within the reservoir 510 and may bemoveable in an axial direction of the reservoir 510 to expand orcontract the interior volume 512 of the reservoir 510. The plunger head520 may be advanced within the reservoir 510 to expel fluidic mediacontained in the interior volume 512 of reservoir 510 out the port 516of the reservoir 510. The plunger head 520 may be made of Bromobutylrubber, silicone rubber, or any other suitable material and/or anyderivative thereof.

The plunger head 520 may have a front portion 522 and a rear portion523. The front portion 522 of the plunger head 520 may be in contactwith fluidic media contained in the interior volume 512 of the reservoir510. The rear portion 523 of the plunger head 520 may be connected orconnectable to an end of the plunger arm 526 in any suitable manner.

A seal member 524, such as an o-ring, may be positioned between thereservoir 510 and the plunger head 520. The interior volume 512 of thereservoir 510 may be on one side of the seal member 524. The reservoir510 may have a chamber 552 located on an opposite side of the sealmember 524 from the interior volume 512 of the reservoir 510. The sealmember 524 may be for substantially preventing fluidic media fromflowing from the interior volume 512 of the reservoir body 110 to thechamber 552 of the reservoir 510. In some embodiments, the seal member524 may be located between the front portion 522 and the rear portion523 of the plunger head 520. The seal member 524 may be made ofsilicone, rubber, or any other suitable material for substantiallypreventing fluid from flowing between the reservoir 510 and the plungerhead 520.

The seal member 524 may have a first end 524 a and a second end 524 b.The first end 524 a of the seal member 524 and the second end 524 b ofthe seal member 524 may taper towards each other to a mid-portion 525.The first end 524 a of the seal member 524 and the second end 524 b ofthe seal member 524 may each be substantially round and tapering to themid-point 525. In some embodiments, the seal member 524 may have apeanut-shaped cross-section.

The first end 524 a of the seal member 524 and the second end 524 b ofthe seal member 524 may contact the reservoir 510. In some embodiments,a space may be located or otherwise formed between the mid-portion 525of the seal member 524 and the reservoir 510, such that the mid-portion525 of the reservoir 510 does not contact the reservoir body 110.

In various embodiments where the reservoir 510 is pre-filled withfluidic media, the reservoir 510 may include a plunger head (e.g., 520)that may be attachable to the delivery device (not shown) as describedabove. In further embodiments, the plunger head may be placed in thereservoir 510 before or after the reservoir 510 is filled with fluidicmedia.

FIGS. 14A-15B illustrate reservoir systems 600 that may be employed asembodiments of the reservoir system 40 discussed above, for deliveringfluidic media in accordance with an embodiment of the present invention.Although the reservoir system 600 may be similar or used with theembodiments of FIGS. 7-13, it should be understood that the reservoirsystem 600 may also include some or all of the same components andoperate in a manner similar to that shown and described in theembodiments of FIGS. 1-6C. In addition, some or all of the featuresshown in FIGS. 1-13 may be combined in various ways and included in theembodiment shown in FIGS. 14A-15B. The reservoir system 600 may include,but is not limited to, a reservoir 610, a plunger head 620, a plungerarm 626, and a seal member 624.

The reservoir 610 may have an interior volume 612 for containing fluidicmedia. The reservoir 610 may have a port 616 for expelling fluidic mediacontained in the interior volume 612 of the reservoir 610. In variousembodiments, the reservoir 610 may be made of various suitablematerials, including, but not limited to, glass, plastic, TOPAS®polymers (or any other cyclic olefin copolymer (or polymer)), or thelike.

The plunger head 620 may be located within the reservoir 610 and may bemoveable in an axial direction of the reservoir 610 to expand orcontract the interior volume 612 of the reservoir 610. The plunger head620 may be advanced within the reservoir 610 to expel fluidic mediacontained in the interior volume 612 of reservoir 610 out the port 616of the reservoir 610. The plunger head 620 may be made of Bromobutylrubber, silicone rubber, or any other suitable material and/or anyderivative thereof.

The plunger head 620 may have a front portion 622 and a rear portion623. The front portion 622 of the plunger head 620 may be in contactwith fluidic media contained in the interior volume 612 of the reservoir610. The rear portion 623 of the plunger head 620 may be connected orconnectable to an end of the plunger arm 626 in any suitable manner.

A seal member 624, such as an o-ring, may be positioned between thereservoir 610 and the plunger head 620. The interior volume 612 of thereservoir 610 may be on one side of the seal member 624. The reservoir610 may have a chamber 652 located on an opposite side of the sealmember 624 from the interior volume 612 of the reservoir 610. The sealmember 624 may be for substantially preventing fluidic media fromflowing from the interior volume 612 of the reservoir body 610 to thechamber 652 of the reservoir 610. The seal member 624 may be made ofsilicone, rubber, or any other suitable material for substantiallypreventing fluid from flowing between the reservoir 610 and the plungerhead 620.

In some embodiments, the seal member 624 may be located at leastpartially between the front portion 622 and the rear portion 623 of theplunger head 620. The plunger head 620 may have a groove 625 surroundinga perimeter of the plunger head 620 with a first ridge 621 a of theplunger head 620 and a second ridge 621 b of the plunger head 620defining the groove 625. The seal member 624 may be arranged at leastpartially in the groove 625 of the plunger head 620.

Protrusions 628 may be arranged or otherwise formed on the first ridge621 a and/or the second ridge 621 b. The protrusions 628 may be forstabilizing the plunger head 620 as the plunger head 620 moves withinthe reservoir body 610. The protrusions 628 may stabilize the plungerhead 620 by substantially preventing movement (e.g., pivotal or lateralmovement) of the plunger head 620, for example, in directions M1 and M2.In other words, the protrusions may prevent excessive perpendicularityof the plunger head 620 relative to the reservoir body 610. Theprotrusions 628 may control compression of the seal member 624. Theprotrusions 628 on the first ridge 621 a may or may not be aligned withthe protrusions 628 on the second ridge 621 b. The protrusions 628 maybe formed on the plunger head 628 or may be attached to the plungerhead, for example, with an adhesive, friction fit, or the like.

In some embodiments, such as the embodiment exemplified in FIG. 14B, sixprotrusions 628 may be arranged equidistantly around each of the firstridge 621 a and the second ridge 621 b. However, in other embodiments,the protrusions 628 need not be so limited as the protrusions 628 may bearranged in any suitable manner. For example, the first ridge 621 aand/or the second ridge 621 b may have any number of protrusions 628;the first ridge 621 a and the second ridge 621 b need not have equalnumber of protrusions 628; the first ridge 621 a and the second ridge621 b may each extend different distances from the plunger head 620;and/or each protrusion 628 need not be equidistant from each other.

In some embodiments, the protrusions 628 may extend a distance D awayfrom the first ridge 621 a and/or the second ridge 621 b and the sealmember 624 may extend a distance 2D beyond the first ridge 621 a and/orthe second ridge 621 b. In further embodiments, D may be selected basedon the reservoir body 610 selected. In other embodiments, theprotrusions 628 and/or the seal member 624 may extend beyond the firstridge 621 a and/or the second ridge 621 b any suitable distance.

In some embodiments, the plunger head 620 may include additional ridges621 c-621 n each separated by a groove 625 containing a seal member 624,as exemplified in FIG. 15A. Any of the additional ridges 621 c-621 n mayinclude protrusions 628 as previously described. In some embodiments,each or some of the first ridge 621 a, the second ridge 621 b, and/orthe additional ridges 621 c-621 n need not be separated by a groove 625and/or a seal member 624. For example, a second ridge 621 b and a thirdridge 621 c may be adjacent to each other with a seal member 624arranged between the first ridge 621 a and the second ridge 621 b, asexemplified in FIG. 15B.

In various embodiments where the reservoir 610 is pre-filled withfluidic media, the reservoir 610 may include a plunger head (e.g., 620)that may be attachable to the delivery device (not shown) as describedabove. In further embodiments, the plunger head may be placed in thereservoir 610 before or after the reservoir 610 is filled with fluidicmedia.

The embodiments disclosed herein are to be considered in all respects asillustrative, and not restrictive of the invention. The presentinvention is in no way limited to the embodiments described above.Various modifications and changes may be made to the embodiments withoutdeparting from the spirit and scope of the invention. The scope of theinvention is indicated by the attached claims, rather than theembodiments. Various modifications and changes that come within themeaning and range of equivalency of the claims are intended to be withinthe scope of the invention.

What is claimed is:
 1. A system for transferring fluidic media, thesystem comprising: a reservoir body having an interior volume forcontaining fluidic media and an opening; a plunger head moveable in anaxial direction within the reservoir body; a plunger arm operativelyconnected to the plunger head, the plunger arm having an arm portionextending out of the opening of the reservoir body for operativelyengaging a drive member configured to move the plunger arm and theplunger head relative to the reservoir body when the arm portion isoperatively engaged to the drive member; a reservoir cover covering atleast a portion of the opening of the reservoir body; and a casingconcentrically surrounding the plunger arm for supporting or aligningthe plunger arm, wherein the casing is fixed to the reservoir cover soas to extend from the reservoir cover along the axial direction to allowthe plunger arm to move in the axial direction relative to the casinoand the reservoir body to move the plunger head in the axial directionwithin the reservoir body.
 2. The system of claim 1, the plunger armhaving at least one side adjacent the casing and at least partiallysupported by the casing to align the plunger arm for movement in theaxial direction relative to the reservoir body.
 3. The system of claim2, the plunger arm having at least two sides adjacent the casing and atleast partially supported by the casing to align the plunger arm formovement in the axial direction relative to the reservoir body, the atleast two sides comprising a first side and a second side opposite thefirst side, the first side and the second side parallel the axialdirection.
 4. The system of claim 1, the casing having an opening forallowing the arm portion of the plunger arm to operatively engage thedrive member through the opening.
 5. The system of claim 4, the openingfor allowing a mating portion of the drive member to extend through theopening to operatively engage the arm portion of the plunger arm withinthe interior of the casing.
 6. The system of claim 1, further comprisinga plurality of protuberances positioned on a surface of the plunger arm,the protuberances on the surface of the plunger arm for contacting aninterior surface of the casing.
 7. The system of claim 1, the plungerarm having a surface having concavities and convexities, the convexitieson the surface of the plunger arm for contacting an interior surface ofthe casing.
 8. The system of claim 1, further comprising a plurality ofprotuberances positioned on an interior surface of the casing, theprotuberances on the interior surface of the casing for contacting theplunger arm.
 9. The system of claim 1, the casing having an interiorsurface having concavities and convexities, the convexities on theinterior surface of the casing for contacting the plunger arm.
 10. Thesystem of claim 1, further comprising a support flange having a firstside and a second side, the first side of the support flange connectedto a side of the plunger arm, the second side of the support flangeconnected to a surface of the plunger head that is operatively connectedto the plunger arm.
 11. The system of claim 1, wherein the plunger armis fully enclosed within the interior of the casing.
 12. The system ofclaim 1, the system further comprising a bias member supported in theinterior of the casing to be between a wall of the casing and theplunger arm, the bias member configured to force the plunger arm againstthe drive member to operatively engage the plunger arm to the drivemember.
 13. The system of claim 1, the casing configured to fit in theend of the reservoir body.
 14. The system of claim 1, the easing havinga mating portion for mating with a mating portion of the end of thereservoir body.
 15. The system of claim 1, the easing having a widthdimension and a thickness dimension transverse to each other; thereservoir body having a width dimension and a thickness dimensiontransverse to each other, the width dimension and the thicknessdimension of the reservoir body transverse the axial direction; whereinthe width dimension and the thickness dimension of the reservoir bodyare each equal to or greater than the width dimension and the thicknessdimension of the casing, respectively.
 16. The system of claim 1, thereservoir body having a port for transferring fluidic media contained inthe interior volume; the interior volume defined by a reservoir wall andan end of the reservoir body, the end of the reservoir body opposite theport of the reservoir body; the plunger head arranged in the interiorvolume between the end and the port of the reservoir to be moveable inthe axial direction within interior volume of the reservoir body; theeasing connected to the end of the reservoir body so as to extend fromthe reservoir body along the axial direction to allow the plunger arm tomove in the axial direction relative to the reservoir body to move theplunger head in the axial direction within the reservoir body.
 17. Thesystem of claim 1, wherein the casing is integral with the reservoircover.
 18. A method of making a system for transferring fluidic media,the method comprising: providing a reservoir body having an interiorvolume for containing fluidic media; locating a plunger head moveable inan axial direction within the reservoir body; operatively connecting aplunger arm to the plunger head, the plunger arm having an arm portionextending out of an opening of the reservoir body for operativelyengaging a drive member configured to move the plunger arm and theplunger head relative to the reservoir body when the arm portion isoperatively engaged to the drive member; and supporting concentricallythe plunger arm for movement in an interior of a casing and relative tothe casing, the casing supporting or aligning the plunger arm, whereinthe casing is fixed to a reservoir cover covering at least a portion ofthe opening of the reservoir body so as to extend from the reservoircover along the axial direction to allow the plunger arm to move in theaxial direction relative to the casing and the reservoir body to movethe plunger head in the axial direction within the reservoir body.
 19. Asystem for transferring fluidic media, the system comprising: areservoir having an interior volume for containing fluidic media and anopening; a reservoir cover covering at least a portion of the opening; aplunger head enclosed within the reservoir, the plunger head moveable inan axial direction within the reservoir, the plunger head comprising: afront portion in contact with fluidic media when fluidic media is in theinterior volume of the reservoir, the front portion comprising a firstmaterial compatible with fluidic media in the interior volume of thereservoir; a rear portion located on an opposite side of the plungerhead from the interior volume of the reservoir, the rear portionconnectable to a plunger arm, the rear portion comprising a secondmaterial different from the first material, the second materialincompatible with the fluidic media in the interior volume of thereservoir, wherein the plunger arm extends out of the opening of thereservoir and is concentrically surrounded by a casing, which is fixedto the reservoir cover, the casing for supporting or aligning theplunger arm, the plunger arm being moveable relative to the casing. 20.The system according to claim 19, further comprising a seal memberpositioned between the reservoir and the plunger head.
 21. The systemaccording to claim 20, the seal member positioned between the frontportion and the rear portion of the plunger head.
 22. The systemaccording to claim 19, further comprising a connection structure thatremovably attaches the front portion of the plunger head to the rearportion of the plunger head and allows removal of the front portion ofthe plunger head from the rear portion of the plunger head.
 23. Thesystem according to claim 19, wherein the front portion of the plungerhead has a diameter that is substantially equal to a diameter of therear portion of the plunger head.
 24. The system of claim 23, whereinthe diameter of the front portion of the plunger head is equal to thediameter of the rear portion of the plunger head.
 25. The systemaccording to claim 19, wherein the front portion and the rear portion ofthe plunger head is are each entirely enclosed in the reservoir.
 26. Thesystem of claim 19, the front portion and the rear portion of theplunger head each having a thickness dimension extending in the axialdirection, the reservoir body having a thickness dimension extending inthe axial direction, the thickness dimensions of the reservoir bodygreater than the front portion and the rear portion of the plunger headcollectively.
 27. A method of making a system for transferring fluidicmedia, the method comprising: providing a reservoir having an interiorvolume for containing fluidic media and an opening, wherein the openingis covered by a reservoir cover; locating a plunger head enclosed withinthe reservoir, the plunger head moveable in an axial direction withinthe reservoir, the plunger head having a front portion and a rearportion, the from portion in contact with fluidic media when fluidicmedia is in the interior volume of the reservoir, the front portioncomprising a first material compatible with fluidic, media in theinterior volume of the reservoir, the rear portion located on anopposite side of the plunger head from the interior volume of thereservoir, the rear portion connectable to a plunger arm, the rearportion comprising a second material different from the first material,the second material incompatible with the fluidic media in the interiorvolume of the reservoir, wherein the plunger arm extends out of theopening of the reservoir and is concentrically surrounded by a casing,which is fixed to the reservoir cover, the casing for supporting oraligning the plunger arm, the plunger arm being moveable relative to thecasing.
 28. A system for transferring fluidic media, the systemcomprising: a plunger arm operatively connectable to a plunger head thatis moveable in an axial direction within a reservoir, the plunger armhaving an arm portion extending out of an opening of the reservoir bodyand that is configured for operative engagement to a drive memberconfigured to move the plunger arm and the plunger head when the armportion of the plunger arm is operatively engaged to the drive member; acasing concentrically surrounding the plunger arm for supporting oraligning the plunger arm, wherein the casing is fixed to a reservoircover covering at least a portion of a reservoir opening so as to extendfrom the reservoir cover along the axial direction to allow the plungerarm to move in the axial direction relative to the casing and thereservoir body to move the plunger head in the axial direction withinthe reservoir body; and a bias member operatively engaged with thecasing, the bias member configured to force the plunger arm against thedrive member to operatively engage the plunger arm to the drive member.29. The system of claim 28, the bias member positioned between thecasing and the plunger arm.
 30. The system of claim 28, the easinghaving an opening for allowing the arm portion of the plunger arm tooperatively engage the drive member.
 31. The system of claim 30, theopening for allowing a mating portion of the drive member to extendthrough the opening to operatively engage the arm portion of the plungerarm within the interior of the casing.
 32. The system of claim 28,further comprising an outer casing configured to enclose at least aportion of the drive member and at least a portion of the plunger arm.33. The system of claim 32, the bias member positioned between the outercasing and the plunger arm.
 34. A method of making a system fortransferring fluidic media, the method comprising: providing a plungerarm operatively connectable to a plunger head that is moveable in anaxial direction within a reservoir, the plunger arm having an armportion extending out of an opening of the reservoir body and that isconfigured liar operative engagement to a drive member configured tomove the plunger arm and the plunger head when the arm portion of theplunger arm is operatively engaged to the drive member; providing acasing concentrically surrounding the plunger arm for supporting oraligning the plunger arm, wherein the casing is fixed to a reservoircover covering at least a portion of an opening of the reservoir so asto extend from the reservoir cover along the axial direction to allowthe plunger arm to move in the axial direction relative to the casingand the reservoir body to move the plunger head in the axial directionwithin the reservoir body; and providing a bias member operativelyengaged with the casing, the bias member configured to force the plungerarm against the drive member to operatively engage the plunger arm tothe drive member.